MAUDE Adverse Event Report: MAQUET SAS PRISMATIC; LAMP, SURGICAL

Catalog Number ARD567027999

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of our surgical lights - prismatic.As it was stated, the label of the device was missing.No injury was reported due to mentioned issue, however, we decided to report this case in abundance of caution as label falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Manufacturer Narrative

The correction of d4 serial # deems required.This is based on the internal evaluation.Previous d4 serial #: (b)(6).Corrected d4 serial #: (b)(6).Getinge became aware of an issue with one of our surgical lights - prismatic.As it was stated, serial number was missing from the label.No injury was reported due to mentioned issue, however, we decided to report this case in abundance of caution as label falling off into sterile field or during procedure may cause contamination.Further information provided by getinge technician indicated that serial number wore off and it was no longer visible on the identification label.It was established that when the event occurred, the surgical light did not meet its specification due to serial number missing from device¿s label, which contributed to the event.Based on additional input from getinge technician it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of peeling off or missing particles of the label, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.It is not likely that the issue could lead to the serious injury or death when the malfunction reoccurs.That is why it is not considered to be safety related and reportable.As stated by subject matter expert at manufacturer¿s, the serial number from the label came off probably due to excessive friction during cleaning or inappropriate cleaning products and hard knocks which could cause scratches, chips and other damages.Maintenance instructions are always included in user manual delivered with each maquet sas device.Therefore, the most probable root cause of such an issue is improper use.We believe the related devices are performing correctly in the market.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: PRISMATIC
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 13786627
• MDR Text Key: 287587233
• Report Number: 9710055-2022-00076
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ARD567027999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/16/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/1997
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1